MedTech Europe: Vision for MDR/IVDR Reform
On 7 November 2023, MedTech Europe published a position paper on the Medical Devices Regulation (MDR (EU) 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR (EU) 2017/746). In the report, the association presents its vision for a regulated legal framework and outlines possible solutions to the ongoing challenges, which have not been overcome after the implementation phase of the MDR and IVDR.
The 12-page position paper, "The Future of Europe's Medical Technology Regulations", follows an open letter from MedTech Europe, together with 34 national associations, to the EU Health Commissioner in September (we reported).
The association once again calls for a fundamental reform and for structural changes to the two regulations so that both patients and European healthcare systems can benefit.
The reform should focus on the three key areas efficiency, innovation and governance while maintaining the high level of safety and performance of the regulations. For each of the three key areas, MedTech Europe identifies principles for success and proposes a number of solutions. These include:
- An efficient CE marking system that improves predictability, reduces administrative burden, and adapts to external changes.
- A system that works for innovation with the inclusion of an innovation principle that swiftly connects the latest medical technologies to European patients and health systems through dedicated assessment pathways and early dialogues with developers.
- An accountable governance structure with the establishment of a single, dedicated structure to oversee and manage the regulatory system, including the designation and oversight of Notified Bodies, with the authority to make system-level decisions.
The need for all stakeholders to work closely together to achieve the original objectives of IVDR and MDR is explicitly emphasized, as it was already in the open letter.
Source:
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